MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as an unknown cook filter.Occupation: non-healthcare professional.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a unknown filter on (b)(6) 2011.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Manufacturer Narrative

H6 (device code): appropriate term/code not available (3191) for alleged device perforation h6 (device code): appropriate term/code not available (3191) for alleged device tilt investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc) perforation, deep vein thrombosis (dvt), tilt, shortness of breath, limited physical activity.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported shortness of breath and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog, filter type and lot number are unknown.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right femoral vein due to retroperitoneal bleeding, contraindication to anticoagulation for deep vein thrombosis/dvt)/pulmonary embolism (pe) prophylaxis.Patient is alleging device tilt and vena cava perforation.Patient notes and further alleges experiencing "shortness of breath", limited physical ability.Per a (b)(6) 2018 computed tomography (ct) abdomen: "indication: transabdominal greenfield filter, deep vein thrombosis of the right lower extremity"."impression: no acute process is noted within the abdomen.There is an ivc filter in place." (b)(6) 2018 independent review of ct abdomen and pelvis dated (b)(6) 2018: "positive for caval perforation.Superior extent of ivc filter mid l1 vertebral body.Inferior extent l2-l3 disc space.A total of 4 prongs have perforated ivc series 2 image 28.Maximum distance prongs perforated 8.70 mm series 2 image 28.Coronal images 5.17 degree tilt left to right 4 image 35.Sagittal images 2.19 degree tilt anterior to posterior series 5 image 50.Diameter of ivc directly above filter 34.56 mm x 24.82 mm series 2 image 18.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9640895
• MDR Text Key: 176752348
• Report Number: 3002808486-2020-00121
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 111